Early Feasibility Study for the Foldax Tria Aortic Heart Valve

Not Applicable

Active, not recruiting

• Conditions: Aortic Valve Stenosis; Aortic Valve Disease
• Interventions: Device: Foldax Tria Aortic Valve

• Registration Number: NCT03851068
• Lead Sponsor: Foldax, Inc

Brief Summary

The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Aortic Valve to collect evidence on the device's safety and performance. The study is anticipated to confirm successful clinical safety and clinical effectiveness with significant improvements in clinical hemodynamic performance.

Detailed Description

The Foldax Polymer Aortic Valve is indicated as a replacement for a diseased, damaged, or malfunctioning native aortic heart valve via open heart surgery. This is a first in human study conducted under US FDA's Early Feasibility Investigational Device Exemption and will enroll up to 40 patients. These patients will be followed up to 5 years after implantation.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-22
• Study Start: 2019-06-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Is 18 years or older
2. Provide written informed consent prior to trial procedures after standard of care studies and tests indicate that the patient needs aortic valve replacement
3. Agrees to attend all follow-up assessments for up to 5 years and is willing to comply with specified follow-up evaluations for the FOLDAX Clinical trial
4. Diagnosed with symptomatic aortic valve disease (stenosis and/or regurgitation) where aortic valve replacement is recommended based on pre-operative evaluations

Exclusion Criteria

1. Requires multiple valve replacement / repair
2. Requires emergency surgery
3. Has had prior valve surgery
4. Requires a surgical procedure outside of the cardiac area
5. Requires a cardiac procedure other than a CABG or root enlargement
6. Requires or are planning another unrelated surgery within 12 months of undergoing implantation of the study device
7. Has active endocarditis/myocarditis or within 3 months to the scheduled surgery
8. Has renal insufficiency as determined by creatinine (S-Cr) level as ≥ 1.5 mg/dl or endstage renal disease requiring chronic dialysis at screening visit
9. Has MRI or CT scan confirmed stroke, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 3 months (90 days) prior to planned valve surgery
10. Has acute myocardial infarction (Ml) within 30 days prior to planned valve surgery
11. Has life expectancy to less than 12 months
12. Diagnosed with hypertrophic obstructive cardiomyopathy (HOCM), except patients who have isolated subaortic muscular hypertrophy diagnosed at the time of surgery
13. Diagnosed with abnormal calcium metabolism and/or hyperparathyroidism
14. Echocardiographic left ventricular ejection fraction <25%
15. Echocardiographic evidence of an intra-cardiac thrombus or vegetation
16. Hemodynamic or respiratory instability requiring inotropic support, mechanical circulatory support, or mechanical ventilation within 30 days prior to planned valve surgery
17. Documented leukopenia (WBC < 4.0 x 103/µL), acute anemia (Hgb < 10.0 gm/dl or 6 mmol/L), thrombocytopenia (platelet count < 100 x103/µL) or history of bleeding diathesis or coagulopathy
18. Has prior organ transplant or is currently an organ transplant candidate
19. Current or recent participation (within 6 weeks prior to surgery) in another drug or device trial
20. Pregnant, lactating or planning to become pregnant during the duration of participation in trial
21. Currently incarcerated or unable to give voluntary informed consent
22. Documented history of substance (drug or alcohol) abuse within the last 5 years prior to implant
23. Requires concomitant left ventricular assist device (LVAD) placement, Impella placement, and/or intra-aortic balloon pump
24. Tests positive for an active infection with SARS-CoV-2 (COVID-19)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tria Aortic Valve	Foldax Tria Aortic Valve	Patients receiving the Foldax Tria Aortic Valve

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoints: Surgical Valve Events Rate Assessment	12 months following patient enrollment completion	The rates of other events will be compared to clinical outcomes for surgically implanted heart valves reported in the literature. a. All-caused death b. Valve related death c. Valve-related reoperation d. Valve explant e. Hemorrhage f. All-cause reoperation g. Valve-related death
Primary Effectiveness Endpoint: New York Heart Association Improvement Assessment	12 months following patient enrollment completion	Clinically significant improvement (one grade) in the New York Heart Association (NYHA) functional classification status at 365 days compared to baseline. a. Class I - No symptoms and no limitations in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. b. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. c. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100m). Comfortable only at rest. d. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Primary Safety Endpoints: Objective Performance Criteria for Flexible Heart Valve Events Assessments	12 months following patient enrollment completion	The adverse events consistent with the Objective Performance Criteria (OPC), for flexible heart valves will be compared to those rates defined as acceptable levels in the standard. a. Thromboembolism b. Valve Thrombosis c. Major Paravalvular leak d. Major Hemorrhage e. Endocarditis
Primary Effectiveness Endpoint: Hemodynamic Performance Assessment	12 months following patient enrollment completion	Hemodynamic performance parameters are mmHG mean gradient and derived Effective Orifice Area (EOA). Success is defined as clinically significant improvement in hemodynamic performance (Effective Orifice Area (EOA)) at one year based on literature reports for surgical aortic valve replacement.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint: Hemolysis screen	12 months post procedure	Hemolysis screen is measured by blood tests including hemoglobin and liver enzyme assessments
Secondary Endpoint: Ventilation Time	30 Days post procedure	Ventilation time in hours defined as arrival time/date in recovery in hours and minutes to date and time extubated in hours and minutes
Secondary Endpoint: Length of Stay in Hospital	30 days post procedure	Post procedure length of stay defined as the date and time in hours and minutes documented for arrival in the recovery unit to date and time in hours and minutes of discharge in hours and minutes.
Secondary Endpoint: ICU Duration of Stay	30 days post procedure	Length of stay in the ICU post valve implantation defined as arrival time/date in hours and minutes to transfer to floor time/date in hours and minutes.
Secondary Endpoint: New Onset Atrial Fibrillation	12 Months post procedure	New/post-operative atrial fibrillation - confirmed on ECG after closure during initial or subsequent admission or at one-year review
Secondary Endpoint: Readmission	30 days post discharge	Patient readmission to the hospital post discharge measured by date/time
Secondary Endpoints: Stroke	5 years following patient enrollment	Assessment of patient experiencing a stroke verified by imaging and or physical exam
Secondary Endpoint: Transient Ischemic Attack	5 Years following patient enrollment	Assessment of patient having a TIA verified by imaging and or physical exam
Secondary Endpoint: Change in Quality of Life (QOL)	12 months post procedure	Change in QOL as measured by the Kansas City Cardiomyopathy Questionnaire

Trial Locations

Locations (5)

St. Vincent Hospital; 🇺🇸 Indianapolis, Indiana, United States

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

OhioHealth Riverside; 🇺🇸 Columbus, Ohio, United States

Ascension Via Christi St. Francis Hospital; 🇺🇸 Wichita, Kansas, United States

William Beaumont Hospital; 🇺🇸 Detroit, Michigan, United States